FDA recommends health professionals prescribe no more than 325 mg of acetaminophen per dose
SILVER SPRING, Md. — The Food and Drug Administration on Tuesday recommended healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit.
There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury, the agency noted. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant and death.
"We recommend that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. We also recommend that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen," the agency stated. "A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product."
In January 2011 the FDA asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. "We requested this action to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain or pain following dental procedures," the FDA noted.
More than half of manufacturers have voluntarily complied with the request, FDA reported. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available. "In the near future we intend to institute proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market," the agency stated.
Acetaminophen is also widely used as an over-the-counter pain and fever medication, and is often combined with other ingredients, such as cough and cold ingredients. The FDA plans to address OTC acetaminophen products in another regulatory action.
Pharmavite expands gummy line with three new products
NORTHRIDGE, Calif. — Pharmavite on Wednesday announced the expansion of its Nature Made Adult Gummies product line. The line extension will include Nature Made Adult Gummies Multi + Omega-3, Nature Made Adult Gummies Energy B12 and Nature Made Adult Gummies Immune Complex with Zinc.
The new offerings are being released at the start of the year when many consumers are looking to get back on track and refocus their wellness routines, the company stated.
Nature Made Adult Gummies Multi + Omega-3 provides key nutrients needed for daily nutritional support plus omega-3 benefits from fish oil. Ensuring an adequate intake of key nutrients is important to supporting overall health. Additionally, omega-3s, including EPA and DHA, help support a healthy heart.
Nature Made Adult Gummies Energy B12 contain 1,000 mcg of vitamin B-12 per serving to support cellular energy production by helping the body convert food into energy. Vitamin B12 is also essential for red blood cell formation, and helps to support nervous system health, the company noted.
Nature Made Adult Gummies Immune Complex with Zinc contain nutrients to help support the immune system. Zinc, which also helps protect the body against free radicals, is a mineral that plays a role in many bodily functions by providing antioxidant support for the immune system.
The Nature Made Adult Gummies line initially launched with seven offerings in the fall of 2012 and included Vitamin C, B Complex, Fish Oil, CoQ10, Calcium, Multi and Vitamin D3. The latest additions will be available in early 2014 at major retailers nationwide.
Former Alacer CEO joins UrgentRx board
DENVER — UrgentRx, developer of fast-acting over-the-counter flavored powder medications, on Tuesday named Ron Fugate to the company’s board of directors.
Previously, Fugate served as president and CEO of Alacer, makers of Emergen-C. Fugate and the Alacer team tripled the size of the Emergen-C business and led a highly competitive sale process that resulted in the sale of the company to Pfizer. Most recently, Fugate was president of YoCrunch (a Catterton Partners portfolio company), driving growth and innovation in the highly competitive yogurt and refrigerated dairy category, culminating with the sale of YoCrunch to Danone.
During his professional career, Fugate also held roles in sales and marketing at blue-chip consumer products companies including Johnson & Johnson, Kellogg’s, and Bristol-Myers Squibb. He has also served on the executive committee and board of the Council for Responsible Nutrition and as a member of the board of the Orange County Business Council.
“There is significant relevance and a strong analog in what UrgentRx is doing within the OTC category with what Ron accomplished at previous companies, notably Emergen-C in the vitamin category,” stated Jordan Eisenberg, president UrgentRx. “His impressive track record of disrupting staid market segments and transforming traditionally boring commodity-driven products into exciting, relevant brands will be a tremendous asset to the UrgentRx team. We look forward to working with him as we continue to build the UrgentRx brand.”
“I like the fact that UrgentRx really understands the needs of today’s consumer and is not afraid to shake things up in the health and beauty universe. UrgentRx products address a significant untapped need and their marketing and strategic direction are right on target," Fugate said.